Reverse Remodeling After PTSMA in Severe But Asymptomatic LVOT Obstruction

NCT04230551 | Unknown

• 1 other identifier: RASTA_V6
• Study Type: interventional
• Target: 15
• Locations: 1 country
• Sites: 2

Brief Summary

Patients with HOCM and severe LVOT obstruction can remain asymptomatic while significant cellular and structural changes of the heart (adverse remodeling) may occur preceding heart failure and rhythm disorders. Hence, preventing adverse remodeling through LVOT desobstruction may have significant impact on cardiac function and geometry in this particular population, as it is in symptomatic patients. The investigators will assess functional and structural characteristics of the myocardium in asymptomatic vs. symptomatic patients with severe LVOT obstruction before and after PTSMA, using advanced imaging studies with LGE-CMR and echocardiography.

Conditions

HOCM, Hypertrophic Obstructive Cardiomyopathy; LVOTO - Left Ventricular Outflow Tract Obstruction; Remodeling, Ventricular

Keywords

HOCM; Hypertrophic Obstructive Cardiomyopathy; Left Ventricular Outflow Tract Obstruction; Adverse Remodeling; Reverse Remodeling; Alcohol Septal Ablation; Percutaneous Transluminal Septal Myocardial Ablation; PTSMA; Extracellular Volume Fraction; Global Longitudinal Strain; Deformation Imaging; 4D Velocity Mapping

Outcome Measures

Primary Outcomes (6)

• Fibrosis

  Extracellular Volume Fraction

  2 years

• Global longitudinal strain (TTE)

  Diastolic Function

  2 years

• Deformation (CMR)

  Shortening Index

  2 years

• Haemodynamics

  Left and Right-Sided Pressure Gradients (TTE)

  2 years

• 4D velocity mapping

  Blood Flow

  2 years

• LV Geometry

  Volume

  2 years

Secondary Outcomes (1)

• New York Heart Association (NYHA) classification

  2 years

Study Arms (3)

Reference Group

ACTIVE COMPARATOR

Five symptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA

Procedure: PTSMA

Study Group

EXPERIMENTAL

Five asymptomatic HOCM patients with severe LVOT obstruction will undergo PTSMA

Procedure: PTSMA

Observation Group

NO INTERVENTION

Five asymptomatic HOCM patients with severe LVOT obstruction will not undergo PTSMA

Interventions

PTSMA PROCEDURE

Alcohol Septal Ablation

Also known as: Alcohol Septal Ablation

Reference Group; Study Group

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age \> 40 yrs
• HOCM diagnosed by experienced cardiologists (European Society of Cardiology (ESC)-certified imaging cardiologists and/or finalized fellowship imaging)
• LVOT obstruction \>30 mmHg pressure gradient in rest, or \>50 mmHg during exercise by TTE and/or invasive measurement, performed experienced (imaging) cardiologists
• Symptomatic (NYHA class \>2 or CCS class \>2)
• Asymptomatic: free of any dyspnea/chest pain or discomfort associated with LVOT obstruction

You may not qualify if:

• LV wall thickness \<15 mm
• Other conditions responsible for hypertrophy (e.g. hypertension, aortic valve disease)
• Moderate to severe mitral valve regurgitation
• Systolic anterior motion of the mitral valve
• Coronary artery disease requiring intervention
• Pregnancy

Sponsors & Collaborators

• St. Antonius Hospital: lead

Study Sites (2)

St. Antonius Hospital

Nieuwegein, 3435CM, Netherlands

NOT YET RECRUITING

St. Antonius Hospital

Nieuwegein, Netherlands

RECRUITING

Related Publications (1)

• Arslan F, Akdim F, Ten Berg JM. Reverse remodeling after percutaneous transluminal septal myocardial ablation in severe but asymptomatic LVOT obstruction (RASTA) study: Rationale and design of transcatheter septal reduction in asymptomatic patients with severe hypertrophic obstructive cardiomyopathy. Catheter Cardiovasc Interv. 2021 Feb 15;97(3):488-492. doi: 10.1002/ccd.29178. Epub 2020 Aug 18.

  PMID: 32808736 DERIVED

MeSH Terms

Conditions

Cardiomyopathy, Hypertrophic; Ventricular Outflow Obstruction, Left; Ventricular Remodeling

Interventions

Ethanol

Condition Hierarchy (Ancestors)

Cardiomyopathies; Heart Diseases; Cardiovascular Diseases; Aortic Stenosis, Subvalvular; Aortic Valve Stenosis; Aortic Valve Disease; Heart Valve Diseases; Ventricular Outflow Obstruction; Pathological Conditions, Anatomical; Pathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Alcohols; Organic Chemicals

Study Officials

• Jurrien M ten Berg, MD PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

• Fatih Arslan, MD PhD

  St. Antonius Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Jurrien M ten Berg, MD PhD

CONTACT

+31 88 320 1121; j.ten.berg@antoniusziekenhuis.nl

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Technicians and/or imaging cardiologists involved in image analysis will not be informed about the procedure in order to have an unbiased analysis at baseline. At follow-up, treated patients will have akinetic/infarcted proximal septum that will be noticed during image acquisition. However, the pre-PTSMA status (symptomatic vs. asymptomatic) will be blinded for the analysis.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: December 31, 2019
• First Posted: January 18, 2020
• Study Start: January 21, 2020
• Primary Completion: December 31, 2023
• Study Completion: January 1, 2024
• Last Updated: September 16, 2021

Record last verified: 2021-09

Data Sharing

• IPD Sharing: Will not share

Locations

NL (2)